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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009851
Receipt No. R000011542
Scientific Title Development of the genetic diagnosis system of congenital and Inherited skin disorders
Date of disclosure of the study information 2013/01/25
Last modified on 2020/01/29

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Basic information
Public title Development of the genetic diagnosis system of congenital and Inherited skin disorders
Acronym Development of the genetic diagnosis system of congenital and Inherited skin disorders
Scientific Title Development of the genetic diagnosis system of congenital and Inherited skin disorders
Scientific Title:Acronym Development of the genetic diagnosis system of congenital and Inherited skin disorders
Region
Japan

Condition
Condition congenital and Inherited skin disorders
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To develop a genetic diagnosis system for congenital and Inherited skin disorders using next generation sequencers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes By this method, we can analyze multiple gene mutations by a single analysis.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Having skin diseases that could be congenital or inherited
Key exclusion criteria Having non-congenital skin disorder
Target sample size 8050

Research contact person
Name of lead principal investigator
1st name Akiharu
Middle name
Last name Kubo
Organization Keio University School of Medicine
Division name Department of Dermatology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL +81-3-3353-1211
Email akiharukubo@gmail.com

Public contact
Name of contact person
1st name Akiharu
Middle name
Last name Kubo
Organization Keio University School of Medicine
Division name Department of Dermatology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email akiharukubo@gmail.com

Sponsor
Institute Department of Dermatology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Dermatology, Keio University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Center for Child Health and Development
Kyoto University, Faculty of Medicine
Tokyo Medical University
Hamamatsu University School of Medicine
Shikoku Medical Center for Children and Adults
University of Occupational and Environmental Health, Japan
Toho University Oomori Hospital
Kinki University
Osaka City University
Shimane University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University Hospital
Address 35 Shinanomachi, Shinjuku, Tokyo
Tel 03-5363-3503
Email akihiro.mitsunaga@adst.keio.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学医学部(東京都)、国立成育医療研究センター(東京都)、京都大学附属病院(京都府)、東京医科大学附属病院(東京都)、浜松医科大学病院(静岡県)、四国こどもとおとなの医療センター(愛媛県)、産業医科大学病院(福岡県)、大阪市立大学医学部附属病院(大阪府)、近畿大学医学部附属病院(大阪府)、東邦大学医療センター大森病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We identified that mutations in SERPINB7 cause Nagashima-type palmoplantar keratosis.
Results date posted
2020 Year 01 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 01 Month 10 Day
Date of IRB
2012 Year 10 Month 11 Day
Anticipated trial start date
2013 Year 01 Month 25 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Under searching genetic mutations in hereditary skin diseases.

Management information
Registered date
2013 Year 01 Month 23 Day
Last modified on
2020 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011542

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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